510(k) · Cleared
ClearedEko Electronic Stethoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eko Devices, Inc. · DQD Stethoscope, Electronic
Cleared on Aug 28, 2015 after a 102-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 17 later devices descend from it.
- Decided
- Aug 28, 2015
- Review
- 102 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 4 citing it directly.
- This deviceK151319 Eko Electronic Stethoscope SystemEko Devices, Inc. · 2015
- Descendant · cites it directly · 13 of its ownK200776 Eko COREEko Devices, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK231551 StethophoneSparrow Acoustics, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK210736 doctorgram Stethoscope DES-IGv Concepts · 2021
- Descendant · 3 generations on · 1 of its ownK240901 StethophoneSparrow Acoustics, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK212975 MedWandMedwand Solutions, Inc. · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K200776Eko COREEko Devices, Inc. · 2020 · cites it directly13descendants
- K231551StethophoneSparrow Acoustics, Inc. · 2023 · 2 generations on2descendants
- K210736doctorgram Stethoscope DES-IGv Concepts · 2021 · 2 generations on2descendants
- K240901StethophoneSparrow Acoustics, Inc. · 2024 · 3 generations on1descendant
- K212975MedWandMedwand Solutions, Inc. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K151319 | Eko Electronic Stethoscope System | Eko Devices, Inc. | 2015 | — |
| +1 | K200776 | Eko CORE | Eko Devices, Inc. | 2020 | — |
| +2 | K231551 | Stethophone | Sparrow Acoustics, Inc. | 2023 | — |
| +2 | K210736 | doctorgram Stethoscope DES-I | Gv Concepts | 2021 | — |
| +3 | K240901 | Stethophone | Sparrow Acoustics, Inc. | 2024 | — |
| +3 | K212975 | MedWand | Medwand Solutions, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQD device
- #1 K200776 Eko COREscore 25.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (17)
See all 174 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K200776 (Eko Devices, Inc., 2020) has gone furthest, with 13 descendants of its own.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DQD
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQD
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQD
No recall names DQD since 2007.
Adverse event reports per year · DQD
1in 2024
MAUDE reports naming product code DQD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 6 | 161 | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 107 | 0 | 1 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 5 | 70 | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 3 | 250 | 0 | 0 |
| 2017 | 4 | 109 | 0 | 0 |
| 2018 | 4 | 131 | 0 | 0 |
| 2019 | 4 | 262 | 0 | 0 |
| 2020 | 6 | 104 | 0 | 0 |
| 2021 | 4 | 137 | 0 | 0 |
| 2022 | 8 | 203 | 0 | 0 |
| 2023 | 10 | 132 | 0 | 0 |
| 2024 | 4 | 153 | 0 | 1 |
| 2025 | 3 | 89 | 0 | 0 |
| 2026 | 6 | 236 | 0 | — |
What is it indicated for?
The Eko Electronic Stethoscope System is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. Eko is intended for use on pediatric and adult patients. It can electronically amplify, filter and transfer sounds to the accompanying mobile application for storage and sharing. It can used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K151319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151319: Eko Electronic Stethoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151319
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026